Investigating Superion™ In Spinal Stenosis

Boston Scientific

Status

Completed

Conditions

Lumbar Spinal Stenosis

Intermittent Claudication

Treatments

Device: X-STOP® IPD® Device

Device: Superion™ Interspinous Spacer

Study type

Interventional

Funder types

Industry

Identifiers

NCT00692276

08-VISS-01

Details and patient eligibility

About

The proposed prospective, multi-center, randomized clinical trial is designed to evaluate the safety and effectiveness of the Superion™ ISS compared to the X-STOP® IPD® device in healthy adults suffering from at least 6 months of moderate spinal stenosis symptoms who have been unresponsive to conservative care.

Full description

Enrollment

391 patients

Sex

All

Ages

45+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male or female subjects ≥ 45 years of age
Persistent leg/buttock/groin pain, with or without back pain, that is relieved by flexion activities (example: sitting or bending over a shopping cart)
Diagnosis of degenerative spinal stenosis of the lumbar spine, defined as the narrowing of the midline sagittal spinal canal (central) and/or narrowing between the facet superior articulating process (SAP), the posterior vertebral margin (lateral recess), and the nerve root canal (foraminal)
Must be able to sit for 50 minutes without pain and to walk 50 feet or more

Exclusion criteria

Axial back pain only
Fixed motor deficit
Diagnosis of lumbar spinal stenosis which requires any direct neural decompression or surgical intervention other than those required to implant the control or experimental device
Unremitting pain in any spinal position
Significant peripheral neuropathy or acute denervation secondary to radiculopathy
Lumbar spinal stenosis at more than two levels determined pre-operatively to require surgical intervention
Significant instability of the lumbar spine as defined by 3mm translation or 5 degrees angulation
Sustained pathologic fractures of the vertebrae or multiple fractures of the vertebrae and/or hips
Spondylolisthesis or degenerative spondylolisthesis greater than grade 1.0 (on a scale of 1 to 4)
Spondylolysis (pars fracture)
Morbid obesity, defined as Body Mass Index (BMI) greater than 40kg/m2
Insulin-dependent diabetes mellitus
Prior surgery of the lumbar spine
Cauda equina syndrome (defined as neural compression causing neurogenic bowel or bladder dysfunction)
Infection in the disc or spine, past or present
Paget's disease at involved segment or metastasis to the vertebra, osteomalacia, or other metabolic bone disease
Tumor in the spine or a malignant tumor except for basal cell carcinoma
Involved in pending litigation of the spine or worker's compensation related to the back